Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION August 27, 2026 Gebauer Company Amy Paukovits Official Correspondent 4444 E. 153rd St. Cleveland, Ohio 44128 Re: K260870 Trade/Device Name: Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist and Medium Spray) Regulatory Class: Unclassified Product Code: MLY Dated: March 17, 2026 Received: March 17, 2026 Dear Amy Paukovits: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1} K260870 - Amy Paukovits Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See {2} K260870 - Amy Paukovits Page 3 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, CHUN XU -S For Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K260870 Device Name Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist and Medium Spray) Indications for Use (Describe) Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray): a vapocoolant (skin refrigerant) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips) and minor open wounds. Gebauer's Pain Ease controls pain associated with minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses, and sutures), injections (venipuncture, IV starts, cosmetic procedures) and temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) **CONTINUE ON A SEPARATE PAGE IF NEEDED.** This section applies only to requirements of the Paperwork Reduction Act of 1995. **\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} GEBAUER COMPANY # K260870 – 510(k) SUMMARY Submitter Information Company Name: Gebauer Company Company Address: 4444 East 153rd street Cleveland, OH 44128 Company Phone: (216) 581-3030 Company Facsimile: (216) 581-4970 Contact Person: Amy Paukovits Director of Regulatory and Quality Affairs amy.paukovits@gebauer.com Date: 8/26/2026 Device Identification Device Trade Name: Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist and Medium Spray) Common Name: Cold Spray (Skin Refrigerant) Models: 0386-0008-13 – Medium Stream, 3.9 fl. oz. (115 ml) 0386-0008-12 – Mist Spray, 3.9 fl. Oz (115 ml) 0386-0008-14 – Medium Spray, 1.2 fl. Oz. (35 ml) 0386-0008-11 – Mist Spray, 1.2 fl. Oz. (35 ml) Classification Name(s): Vapocoolant Device Regulation(s): Unclassified Device Class: Unclassified Product Code(s): MLY Advisory Panel: Physical Medicine {5} ## Identification of Predicate Devices The Subject Device is substantially equivalent to the following devices: | Device Name | Classification Name/ Regulation | Product Code | 510(k) Number | Clearance Date | | --- | --- | --- | --- | --- | | Gebauer's Pain Ease | Vapocoolant Device/Unclassified | MLY | K172028 | 10/27/2017 | | PainFreeze II | Vapocoolant Device/Unclassified | MLY | K232674 | 2/12/2024 | ## Device Description The Subject Device consists of a chemical blend of 90% HFO-1233zd (Trans-1 -chloro- 3,3,3-trifluoropropene) and 10% HFO-1234ze (trans- 1,3,3,3-tetrafluoroprop- 1 – ene). The blend self-propels itself from the aerosol delivery system which is designed to account for its low vapor pressure. The delivery systems consist of an aluminum aerosol can, valve and actuator. The blend produces a cooling effect upon contact with the skin, intact mucous membranes, and minor open wounds, when delivered in either a medium stream or mist spray. The blend begins to evaporate immediately upon contact with the skin, the evaporation rate of the blend is what produces the coldness. Both the Subject Device and the Predicate Devices can be applied via direct spray or by following cotton application using a cotton ball, or gauze (if the skin is breached use this application method with only STERILE, disposable cotton balls or gauze. The cotton balls or gauze are not supplied with the device). ## Indications for Use Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist and Medium Spray): a vapocoolant (skin refrigerant) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips) and minor open wounds. Gebauer's Pain Ease controls pain associated with minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses and sutures), injections (venipuncture, IV starts, cosmetic procedures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). {6} # Summary of Technological Characteristics | Technological Comparison Table – Subject & Predicate Devices | | | | | | --- | --- | --- | --- | --- | | Comparison Feature | Subject Device | Predicate Device: Gebauer's Pain Ease | Predicate Device: PainFreeze II | Similarities/Differences | | Device Name | Gebauer's Pain Ease | Gebauer's Pain Ease | PainFreeze II | | | Manufacturer | Gebauer Company | Gebauer Company | Nuance Medical, Inc. | | | 510(k) Number | K260870 | K172028 | K232674 | | | Indications for Use | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist and Medium Spray): a vapocoolant (skin refrigerant) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips) and minor open wounds. Gebauer's Pain Ease controls pain associated with minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses and sutures), injections (venipuncture, IV starts, cosmetic procedures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist and Medium Spray); a vapocoolant (skin refrigerant) intended for topical application to skin, mucous membranes and minor open wounds. Gebauer's Pain Ease controls pain associated with minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses and sutures), injections (venipuncture, IV starts, cosmetic procedures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). The Medium Spray is also intended for the management of myofascial pain caused by trigger points, restricted motion and muscle tension. | PainFreeze II Medium Strem and Mist Spray are vapocoolants (skin refrigerants) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passageways, and the lips) and minor open wounds. PainFreeze II's skin refrigerant controls pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical procedures (lancing boils, incisions, drainage of small abscesses, and sutures), and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). | The indications for the subject device do not include the statement "The Medium Spray is also intended for the management of myofascial pain caused by trigger points, restricted motion and muscle tension." The difference in indications does not impact the safety and efficacy of the device. | | Product Configurations | Mist Spray Medium Stream Spray | Mist Spray Medium Stream Spray | Mist Spray Medium Spray | Same | | Chemical Composition | HFO-1233zd (Trans- 1 - chloro-3,3,3-trifluoropropene) 90 % and HFO-1234ze (trans- 1,3,3,3-tetrafluoroprop-1 – ene) 10% | 1,1,1,3,3 Pentafluoropropane (HFC-245fa high purity ) and 1,1,1,2 Tetrafluoroethane (HFC-134a pharmaceutical grade) | HFO-1233zd (Trans- 1 - chloro-3,3,3-trifluoropropene) 60% and HFO-1234ze (trans- 1,3,3,3-tetrafluoroprop-1 – ene) 40% | Temperature performance testing demonstrates that the subject device achieves temperatures of 30°C or below and a temperature decrease of 1°C from ambient temperature across application methods. Biocompatibility testing was conducted in | {7} | Technological Comparison Table – Subject & Predicate Devices | | | | | | --- | --- | --- | --- | --- | | Comparison Feature | Subject Device | Predicate Device: Gebauer's Pain Ease | Predicate Device: PainFreeze II | Similarities/Differences | | | | | | accordance with ISO 10993-1 similar to the predicate devices, thereby supporting the biocompatibility of the subject device. Therefore, the difference in chemical composition does not raise increased safety and/or efficacy concerns compared to the predicate devices. | | Container Size | 3.9 fl. Oz., 1.2 fl. Oz. (115ml, 35 ml) | 103.5ml | 35ml, 115ml | The volume differs, however there is no impact on safety or efficacy. | | Target Population | Adults, and as the safety for use of the device in pediatric patients has not been established, it is recommended the device should not be used on patients under four without consultation of a pediatrician | General | Adults | Same as predicates. | | Patient Contact | Skin, intact mucous membranes, and minor open wounds. | Intact skin, intact mucous membranes, and minor open wounds. | Skin | Same as the K172028 predicate | | Energy Delivery | Thermal energy via refrigerant spray. | Thermal energy via refrigerant spray. | Thermal energy via refrigerant spray. | Same | | Vapocoolant Discharge Method | Depress the actuator to release the vapocoolant. | Depress the actuator to release the vapocoolant. | Handheld spray containers. Button on actuator is pressed. | Same as the K172028 predicate | | Maximum Delivered Volume | 10 grams | Not publicly available | Not publicly available. | Temperature performance testing demonstrates that the subject device achieves temperatures of 30°C or below and a temperature decrease of 1°C from ambient temperature across application methods. Biocompatibility testing was conducted in accordance with ISO 10993-1 similar to the predicate devices, thereby supporting the | {8} | Technological Comparison Table – Subject & Predicate Devices | | | | | | | --- | --- | --- | --- | --- | --- | | Comparison Feature | Subject Device | | Predicate Device: Gebauer's Pain Ease | Predicate Device: PainFreeze II | Similarities/Differences | | | | | | | biocompatibility of the subject device. Therefore, the difference in the maximum delivered volume does not raise increased safety and/or efficacy concerns compared to the predicate devices. | | Degree of Temperature Decrease between application methods | Direct Spray (Min-Max) | Medium: 18-31°C Mist: 3-33°C | Not publicly available. | Not publicly available. | Temperature bench testing of the subject device demonstrates that the subject device achieves temperatures of 30°C or below and a temperature decrease of more than 1°C from ambient temperature, similar to the predicate devices Therefore, differences in the degree of temperature decrease do not raise increased effectiveness concerns compared to the predicate devices. | | | Cotton Ball (Min-Max) | Medium: 7-10°C Mist: 6-13°C | | | | | | Gauze (Min-Max) | Medium: 6-9°C Mist: 7-13°C | | | | | Boiling Point | 14.0°C | | 7.0°C | -3.0 +/-3°C | Bench temperature testing performed demonstrates the device performance is as effective as the predicate devices. | | Mechanism of Action and Operating Principle | Cooling by application of refrigerant. Direct spray application to intact skin, intact oral mucous membranes, and minor open wounds, or application via cotton ball, or gauze. | | Direct spray application to intact skin, intact oral mucous membranes, and minor open wounds, or application via cotton ball, cotton swab or gauze. | Cooling by application of refrigerant; Dispensing valve on canister is depressed to release the refrigerant | Same as the K172028 predicate device. | | Flammability | Non-flammable | | Non-flammable | Non-flammable | Same | | Mechanical Safety | Mechanism has positive shut-off release. | | Mechanism has positive shut-off release. | Mechanism has positive shut-off release | Same | | Manufacturing Environment | Controlled Environment | | Controlled Environment | Not publicly available. | Same | {9} | Technological Comparison Table – Subject & Predicate Devices | | | | | | --- | --- | --- | --- | --- | | Comparison Feature | Subject Device | Predicate Device: Gebauer's Pain Ease | Predicate Device: PainFreeze II | Similarities/Differences | | Microbial Limits Testing | Tested in accordance with USP <61> and <62>. | Tested in accordance with USP <61> and <62>. | Not publicly available | Same | | Biocompatibility Testing | CytotoxicitySensitizationIrritation (Skin and Oral Mucosal)Acute Systemic ToxicityMaterial Mediated Pyrogenicity | In accordance with ISO 10993 for dermal irritation, sensitization, cytotoxicity, oral mucosal irritation, acute dermal toxicity | CytotoxicitySensitizationIrritationAcute Systemic ToxicityMaterial Mediated Pyrogenicity | The Subject Device was tested for Material Mediated Pyrogenicity, similar to the K232674 predicate device | | Shelf-Life | 2 years | 3 years | 24 months | Shelf-life testing conducted for the subject device demonstrates there are no increased safety and/or effectiveness concerns compared to the predicate devices. | | Storage Temperature | Do not store at temperatures above 50°C | Do not store at temperatures above 50°C | Not to exceed 49 °C | Same as the K172028 predicate device. | | Acidity | ≤1ppm (w/w) | Not Publicly Available | Not publicly available | Acidity per USP <541> was established for the subject device to ensure safety when applied to skin. | ### Non-Clinical Testing Assessments were performed that includes the following: - Side-by-Side Temperature Comparison – comparative testing demonstrated similar temperatures to the predicate. - Biocompatibility – Evaluations were conducted per ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process for devices in contact with intact mucous membranes, compromised skin and a limited exposure (<24 hours). Evaluations included: ○ Cytotoxicity ○ Sensitization ○ Skin Irritation ○ Oral Mucosal Irritation ○ Acute Systemic Toxicity ○ Material Mediated Pyrogenicity All test criteria were successfully met for each evaluation. {10} ## Shelf Life Testing The following evaluations were conducted at defined intervals to support the two-year shelf life of the subject device, including: - Visual Inspection - Minimum Fill - GC Purity - GC Composition - Non-Volatile Residue - Appearance - Microbial enumeration/Presence of microorganisms - Acidity Test criteria were met at each assessment interval, which demonstrated the Subject Device's stability ## Clinical Testing Not Applicable ## Conclusions Based on the information above, it is concluded that the Subject Device (Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist and Medium Spray) is substantially equivalent to the K172028 and K232674 predicate devices.